Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
Phase II Randomized Study of Three Different Schedules of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) in Myelodysplastic Syndrome (MDS)
1 other identifier
interventional
128
1 country
1
Brief Summary
The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2003
CompletedFirst Posted
Study publicly available on registry
August 28, 2003
CompletedStudy Start
First participant enrolled
October 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
May 26, 2011
CompletedAugust 7, 2012
August 1, 2012
5.6 years
August 27, 2003
September 25, 2009
August 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant Responses
Objective responses by International Working Group criteria: 'Complete Response' (CR) defined as Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L); 'Other Response' including Partial Remission (PR) defined as above, except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment combined with participants who meet all criteria for CR except for platelet recovery to \>100 x 109/L; and 'No Response'.
Response to treatment after 8 weeks of therapy
Study Arms (3)
Decitabine 10 mg/m^2 IV
ACTIVE COMPARATOR10 mg/m\^2 intravenous (IV) over 1 hour daily for 10 days
Decitabine 20 mg/m2 IV
ACTIVE COMPARATOR20 mg/m2 IV over 1 hour daily for 5 days
Decitabine 20 mg/m2 SQ
ACTIVE COMPARATOR20 mg/m2 subcutaneous (SQ) daily for 5 days
Interventions
10 mg/m\^2 by vein over 1 hour daily for 10 days
Eligibility Criteria
You may qualify if:
- MDS and 5% or more marrow blasts, or IPSS risk intermediate 1-2 or high risk; or chronic myelomonocytic leukemia
- Performance status 0-2 (Eastern Cooperative Oncology Group (ECOG) scale); adequate hepatic (bilirubin \< 2 mg/dl) and renal functions (creatinine \<2mg/dl); New York Heart Association (NYHA) cardiac status III-IV excluded.
- Signed informed consent
- No prior intensive combination chemotherapy or high-dose ara-C (\>/= 1g/m2 per dose). Prior biologic therapies, targeted therapies and single agent chemotherapy allowed.
- Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of Hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy.
You may not qualify if:
- Nursing and pregnant females are excluded. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Patients with active and uncontrolled infections
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Eisai Inc.collaborator
Study Sites (1)
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Oki Y, Jelinek J, Shen L, Kantarjian HM, Issa JP. Induction of hypomethylation and molecular response after decitabine therapy in patients with chronic myelomonocytic leukemia. Blood. 2008 Feb 15;111(4):2382-4. doi: 10.1182/blood-2007-07-103960. Epub 2007 Nov 30.
PMID: 18055864DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Hagop Kantarjian, MD / Professor
- Organization
- The University of Texas M. D. Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Hagop M Kantarjian, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2003
First Posted
August 28, 2003
Study Start
October 1, 2003
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
August 7, 2012
Results First Posted
May 26, 2011
Record last verified: 2012-08